MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Renal Failure (2041); Sepsis (2067); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/01/2019

Event Type  Injury  

Event Description

This research article was a retrospective study designed to evaluate the institutional variations of transcatheter edge-to-edge repair (teer) and also investigate its association with 180-day readmission rates.Complications identified in the study included: hospitalization, heart failure, sepsis, atrial fibrillation, acute kidney injury, pneumonia, and recurrent mr.In conclusion the study found substantial institutional variation in the volume of teer cases.Higher institutional volume was associated with a decreased risk of 180-day readmission rate, particularly in non-elective cases.Details are listed in the attached article titled, "association between institutional volume of transcatheter mitral valve repair and readmission rates: a report from the national readmission database".

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported mr, renal failure, sepsis, and arrhythmia.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.B2, b3, d6: dates estimated.D4: the udi number is not known as the part and lot number were not provided.Article titled "association between institutional volume of transcatheter mitral valve repair and readmission rates: a report from the national readmission database".

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16985125
• MDR Text Key: 315823709
• Report Number: 2135147-2023-02263
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male